mg infertility services commercial - emblemhealth...• mild to moderate male factor infertility •...

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Infertility Services — Commercial Last Review Date: February 14, 2020 Number: MG.MM.ME.53cv2 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to Health Insurance Plan of Greater New York and Group Health Incorporated, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Related Medical Guidelines Recurrent Pregnancy Loss Definitions Infertility “Infertility” is a disease or condition characterized by the incapacity to impregnate another person or to conceive, defined by the failure to establish a clinical pregnancy after twelve (12) months of regular, unprotected sexual intercourse or therapeutic donor insemination, or after six (6) months of regular, unprotected sexual intercourse or therapeutic donor insemination for a female thirty-five (35) years of age or older. Earlier evaluation and treatment may be warranted based on a member’s medical history or physical findings (See also Section 4: IVF for Women without Male Partners or Exposure to Sperm) Iatrogenic infertility An impairment of fertility by surgery, radiation, chemotherapy or other medical treatment affecting reproductive organs or processes. Note: EmblemHealth covers standard fertility preservation services when a medical treatment will directly or indirectly lead to iatrogenic infertility. Standard fertility preservation services include the collecting, preserving, and storing of ova and sperm. IUI Intrauterine insemination (IUI) is a fertility treatment in which a fine catheter is inserted through the cervix into the uterus to deposit a sperm sample directly into the uterus. IVF In Vitro Fertilization (IVF) is an assisted reproductive technology (ART). IVF is the process of fertilization by extracting eggs, retrieving a sperm sample, and then manually combining an egg and sperm in a laboratory dish. The embryo(s) is then transferred to the uterus. Cycle A “cycle” is defined as either all treatment that starts when preparatory medications are administered for ovarian stimulation for oocyte retrieval with the intent of undergoing in- vitro fertilization using a fresh embryo transfer; or medications are administered for endometrial preparation with the intent of undergoing in-vitro fertilization using a frozen embryo transfer. Covered Services

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Page 1: MG Infertility Services Commercial - EmblemHealth...• Mild to moderate male factor infertility • Use of stored sperm from male members who , subsequent to active infertility treatment,

Infertility Services — Commercial

Last Review Date: February 14, 2020 Number: MG.MM.ME.53cv2

Medical Guideline Disclaimer

Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to Health Insurance Plan of Greater New York and Group Health Incorporated, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc.

Related Medical Guidelines Recurrent Pregnancy Loss

Definitions

Infertility “Infertility” is a disease or condition characterized by the incapacity to impregnate another person or to conceive, defined by the failure to establish a clinical pregnancy after twelve (12) months of regular, unprotected sexual intercourse or therapeutic donor insemination, or after six (6) months of regular, unprotected sexual intercourse or therapeutic donor insemination for a female thirty-five (35) years of age or older. Earlier evaluation and treatment may be warranted based on a member’s medical history or physical findings (See also Section 4: IVF for Women without Male Partners or Exposure to Sperm)

Iatrogenic infertility An impairment of fertility by surgery, radiation, chemotherapy or other medical treatment affecting reproductive organs or processes. Note: EmblemHealth covers standard fertility preservation services when a medical treatment will directly or indirectly lead to iatrogenic infertility. Standard fertility preservation services include the collecting, preserving, and storing of ova and sperm.

IUI Intrauterine insemination (IUI) is a fertility treatment in which a fine catheter is inserted through the cervix into the uterus to deposit a sperm sample directly into the uterus.

IVF In Vitro Fertilization (IVF) is an assisted reproductive technology (ART). IVF is the process of fertilization by extracting eggs, retrieving a sperm sample, and then manually combining an egg and sperm in a laboratory dish. The embryo(s) is then transferred to the uterus.

Cycle A “cycle” is defined as either all treatment that starts when preparatory medications are administered for ovarian stimulation for oocyte retrieval with the intent of undergoing in-vitro fertilization using a fresh embryo transfer; or medications are administered for endometrial preparation with the intent of undergoing in-vitro fertilization using a frozen embryo transfer.

Covered Services

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Basic infertility services: Initial evaluation Semen analysis Laboratory evaluation Evaluation of ovulatory function Postcoital test Endometrial biopsy Pelvic ultra sound Hysterosalpingogram Sono-hystogram Testis biopsy Blood tests; and Medically appropriate treatment of ovulatory

dysfunction

Note: Additional tests may be Covered if the tests are determined to be Medically Necessary.

Comprehensive infertility services: Ovulation induction and monitoring Pelvic ultra sound Artificial insemination Hysteroscopy Laparoscopy Laparotomy

Advanced infertility services: Three (3) cycles per lifetime of in vitro

fertilization Sperm storage costs in connection with in vitro

fertilization Cryopreservation and storage of embryos in

connection with in vitro fertilization

New York State Limitations A. Every large group contract that provides medical, major medical or similar comprehensive-type

coverage shall provide coverage for three cycles of in-vitro fertilization (IVF) used in the treatment of infertility

B. Unlimited intrauterine insemination (IUI) for members who meet the clinical definition of infertility (Note: Clinical evidence suggests that greater than 6 IUI cycles is unlikely to yield positive results)

C. Coverage for prescription drugs is limited to medications approved by the federal Food and Drug Administration for use in the diagnosis and treatment of infertility

D. The identification of the required training, experience and other standards for health care providers for the provision of procedures and treatments for the diagnosis and treatment of infertility determined in accordance with the standards and guidelines established and adopted by the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine

E. The determination of appropriate medical candidates by the treating physician in accordance with the standards and guidelines established and adopted by the American College of Obstetricians and Gynecologists and/or the American Society for Reproductive Medicine

Guideline Section 1: Menopause Menopause is defined as the point in time when menstrual cycles cease for 12 consecutive months due to the natural depletion of ovarian oocytes from aging. Menopause does not meet the definition of infertility Donor embryo services not allowed for members after natural menopause

Section 2: Artificial Insemination (IUI) A. Medical Necessity Criteria IUI may be authorized when the definition of infertility is met (see Definitions Section and Section 4: IVF for Women without Male Partners or Exposure to Sperm) and there is documentation of the following:

1. Hysterosalpingography (hysterosalpingogram (HSG) to screen for tubal occlusion; or Hysteroscopy, salpingoscopy (falloscopy), hydrotubation where clinically indicated; or

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Laparoscopy and chromotubation (contrast dye) to assess tubal and other pelvic pathology, and to follow-up on hysterosalpingography abnormalities, within the past 2 years confirming the presence of both:

• At least one patent Fallopian tube • Normal endometrial cavity

2. Normal ovarian reserve testing (FSH Level)

3. Any of the following: • Unexplained infertility • Polycystic Ovary Syndrome (PCOS), anovulation, or oligoovulation • Minimal or mild endometriosis • Cervical factors • Mild to moderate male factor infertility • Use of stored sperm from male members who, subsequent to active infertility

treatment, required sperm banking/storage as a result of medical treatment (e.g., cancer treatment) likely to cause infertility

4. If prior IUI, results must be submitted with each request and demonstrate both: • Adequate ovarian response to stimulation (i.e. at least 2 follicles >12 mm diameter for

any monitored IUI using standard medication doses) • Adequate fresh semen and post wash semen parameters in order to continue with IUI

B. Intra-uterine (IUI) Without Medication Natural IUI, defined as IUI without medication, for a woman who has a diagnosis of infertility (as defined herein), may be covered when the member has documented acceptable ovarian reserve as defined by: For women < 40 years of age: Documentation of acceptable ovarian reserve is not required For women ≥ 40 years of age: FSH level which is < 15mIU/mIU/ml on cycle day 3 and the day 3

Estradiol level in < 80 pg/mL AND the member must meet one of the following:

The woman has a history of one or more cervical surgical procedures or conization procedures that is considered a factor in the woman’s infertility

The woman has a diagnosis of vaginismus Use of therapeutic donor insemination

C. Intra-uterine (IUI) With Medication

Medicated IUI, defined as IUI with medication, for a woman who has a diagnosis of infertility (as defined herein), may be covered for intra-uterine insemination cycles with medication when the following criteria are met: Members age 40 and over must also demonstrate acceptable ovarian reserve as defined by:

For women 40 and 41 years of age: FSH level which is < 15mIU/mIU/ml on Cycle day 3 and the day 3 Estradiol level is < 80 pg/mL

For women > age 42 years of age: FSH level which is < 17 mIU/ml on Cycle day 3 and the day 3 Estradiol level is < 80 pg/mL

AND the member must meet one of the following:

Unexplained infertility Mild–moderate male factor infertility Minimal or mild endometriosis Unilateral tubal factor infertility absent any compromise of the patent fallopian tube

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Polycystic Ovary Syndrome (PCOS), anovulation, or oligoovulation

D. Intrauterine insemination (IUI) is not indicated in any one of the following situations: >1 insemination per cycle Severe male factor infertility (< 1 million motile sperm after sperm preparation) (without use of

donor sperm) Bilateral tubal factor infertility Moderate or severe endometriosis unless treatment has previously been rendered and there is

documentation of at least one uncompromised fallopian tube Recurrent pregnancy loss In the setting of ART in any of the following situations:

• To convert an ART cycle to IUI when at least 3 follicles ≥15 mm in diameter are present (particularly in the setting of diminished ovarian reserve or on the 2nd or greater ART cycle when maximal dosage of gonadotropins is being used)

• Following an ART cycle that fails to result in conception due to poor ovarian response or poor-quality oocytes or embryos

• Following ≥ 2 ART cycles that have failed to result in a conception despite good quality oocytes or embryos

E. IUI after IVF In the absence of an intervening live birth, subsequent IUI cycles are not authorized for

members who have unsuccessfully undergone IVF for infertility treatment when further IVF cycles do not meet medical necessity criteria

Women who have been denied or failed ART services are generally not appropriate candidates for IUI cycles (exceptions based upon an individual’s medical history will be considered)

IUI after IUI-to-IVF conversion for hyperstimulation may be authorized if the stimulation that was initially given is reduced

IUI after IVF/ICSI/Preimplantation Genetic Testing (PGT) may be authorized for couples with a male genetic disorder who opt to use donor sperm after IVF/ICSI/PGT if the female member meets IUI criteria

F. Conversion from IUI to IVF/Hyperstimulation Authorized when the current IUI cycle has resulted in all: Estradiol level of ≥800 pg/ml Production of at least 5 follicles >12 mm in diameter Age <40 Has benefit for IVF available

Section 3: Assisted Reproductive Technology (ART) (May not be covered for all plans) (Note: It is the member’s responsibility to obtain prior approval. Pre-service requests must also include a completed Statement of Medical Necessity for ART — Appendix)

Coverage for IVF services is limited to a benefit maximum of 3 cycles in the State of New York. EmblemHealth does not deny coverage for medically necessary IVF services for any member who foregoes an infertility treatment or procedure if her physician determines that such treatment or procedure is likely to be unsuccessful.

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A. Medical Necessity Criteria

IVF services are authorized when the relevant infertility eligibility criteria are met and there is documentation confirming any of the following: Unexplained infertility Diminished ovarian reserve (not due to age) Ovulatory dysfunction

• When ovulation induction has not resulted in conception • Poor response to ovulation induction • Hyper-response to ovulation induction; hyper-response can convert to IVF

History of failed medicated IUI cycles when IUI criteria (above) have been met (results of prior IUI cycles must be submitted with each IVF request [initial and subsequent requests])

Female member with bilateral Fallopian tube absence (excluding prior elective sterilization) or bilateral Fallopian tube obstruction due to prior tubal disease with history of failed conventional therapy

Female member with severe endometriosis and history of failed medical and surgical therapy

Male member with severe male factor infertility has been evaluated by a urologist who confirms condition cannot be improved by standard conservative treatment(s) and cannot be addressed via IUI

B. IVF Protocol Members must meet above medical necessity criteria For members <35 years of age

• 1st IVF treatment cycle: SET (single embryo transfer) is required If there are no top-quality embryos after thawing, then two or more embryos of

any quality may be transferred 2nd and subsequent IVF treatment cycles: STEET (single thawed elective embryo transfer; aka, SET/FET- SINGLE

EMBRYO TRANSFER- FROZEN EMBRYO TRANSFER) is required if member has one or more embryos frozen

• If there are no top-quality embryos after thawing, then two embryos of any quality may be transferred

Fresh IVF cycle with SET if no frozen embryos available • If there are no top-quality embryos is after thawing, then two

embryos of any quality may be transferred For all treatment cycles, all normal frozen embryos must be used before

another fresh cycle may be approved For members 35–38 years of age

• 1st IVF treatment cycle: SET is required If no top-quality embryo is available, then two embryos of any quality may be

transferred • 2nd and subsequent IVF treatment cycles do not need to be SET or STEET • For all treatment cycles, all normal frozen embryos must be used before another fresh

cycle may be approved

For members <38 years of age and had successful IVF treatment cycle (i.e. had a live birth from that IVF treatment)

• 1st IVF treatment cycle:

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STEET is required if member has one or more embryos frozen • If there are no top-quality embryos after thawing, then two

embryos of any quality may be transferred Fresh IVF cycle with SET if no frozen embryos available

• If only no top-quality embryo is available, then two embryos of any quality may be transferred

• 2nd and subsequent IVF treatment cycles do not need to be SET or STEET • For all treatment cycles, all normal frozen embryos must be used before another fresh

cycle may be approved

Members 38 years of age and older undergoing IVF treatment do not need to attempt a SET or STEET as their risk of multiple births is low

• For all treatment cycles, all normal frozen embryos must be used before another fresh cycle may be approved

C. Frozen Embryo Transfers (FET) Members seeking coverage for FET must meet the definition of infertility and expect fertility as a natural state. It is clinically appropriate and cost effective to utilize all appropriate frozen embryos for transfer

prior to another fresh ART cycle (fresh oocyte retrievals are not indicated when frozen oocytes or embryos are available and appropriate for transfer)

For members with frozen embryos created in an IVF cycle not initially approved by EmblemHealth, the following criteria must be met before embryo transfer may be approved:

• Uterine cavity evaluation completed within the last year • Diagnosis of infertility from treating provider • Fertility is naturally expected for member

D. Embryo Banking There is no evidence in the medical literature to support the practice of repeated ART cycles for the purpose of accumulating (banking) embryos for later use (egg retrievals without a fresh or frozen embryo transfer) with the exception of freeze all cycles for medical necessity.

E. Freeze-All Cycles An ART cycle, when it is known at the initiation of a cycle that none of the resulting embryos will be transferred immediately and/or the intent is to cryopreserve all the embryos for future use, will be covered only if one of the following is met: Member has no prior history of sterilization, in the presence or absence of ongoing infertility

care, when the member requires medical treatment that may render them sterile (Note: A letter of medical necessity from the treating physician is required [e.g., the member has been diagnosed with cancer and will be undergoing chemotherapy and/or radiation that will likely result in infertility])

Member is approved by EmblemHealth for preimplantation genetic testing (PGT) with IVF

Member is eligible for coverage of an IVF cycle based on the definitions and criteria outlined in this guideline and is privately paying for PGT (Note: IVF/PGT testing for gender selection is a benefit exclusion)

The Member’s progesterone concentration (P4) is > 1ng/mL at the time of administration of hCG trigger injection

Management of Ovarian Hyperstimulation Syndrome

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F. Assisted Hatching (AH) Authorized as part of an IVF or Frozen Embryo Transfer (FET) procedure for women > age 38 when documentation confirms either of the following: Failed IVF cycles that produced 3 or more morphologically high-quality embryos, with failure to

implant after embryo transfer Prior pregnancy resulting from IVF that required assisted hatching

Non-covered services include but are not limited to the following: Assisted hatching if PGT is done, as PGT process includes opening the zona (See Preimplantation

Genetic Testing below)

G. ICSI - Intracytoplasmic Sperm Injection (ICSI) Authorized (in conjunction with IVF) to treat sperm-related infertility problems in the male partner when the use of ICSI is expected (with a greater than 5% probability) to result in a live birth, and there is documentation of any of the following: Severe male factor infertility that cannot be overcome by IVF based on semen analysis reports

performed within the last 3 months; any: • At least 2 unprocessed semen analyses show <10 million total motile sperm • At least 2 processed semen analyses show ≤3 million total motile sperm • At least 2 unprocessed semen analyses show ≤ 4% strict Kruger normal forms

Reduced fertilization on a prior IVF cycle using non-donor sperm if the rate of fertilization on the prior cycle is less than 40% fertilization with the standard insemination of mature eggs

Obstruction of the male reproductive tract unrelated to prior sterilization or sterilization reversal, and not amenable to repair (necessitating sperm retrieval via Microsurgical Epididymal Sperm Aspiration)

Nonobstructive azoospermia (necessitating sperm retrieval via Testicular Sperm Extraction)

ICSI is not authorized for any IVF cycle involving use of donor sperm, or solely to perform Preimplantation Genetic Testing (PGT) when PGT has not been authorized (See also Preimplantation Genetic Testing below)

ICSI is covered on the day of IVF egg retrieval if the post processing semen (severe male factor infertility results above must be met) analysis of non-donor non-frozen sperm on that day meets the ICSI coverage criteria noted immediately above. Retrospective authorizations will be allowed

H. Preimplantation Genetic Testing Meets ART criteria above

At least 1 of the following is present: • Both partners are known carriers of a single gene autosomal recessive disorder • One partner is known to have a balanced translocation • One partner has a single gene autosomal dominant disorder • One partner is a known carrier of an x-linked disorder • Testing is being conducted to determine the sex of an embryo, when there is a

documented history of an x-linked disorder and decisions regarding management can be made on the basis of sex alone

Must meet all of the following: • A specific mutation, or set of mutations, has been identified, that specifically identifies

the genetic disorder with a high degree of reliability • The genetic disorder is associated with severe disability or has a lethal natural history

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• Testing is accompanied by genetic counseling

Limitations/Exclusions Based upon the EmblemHealth member documents, preimplantation genetic testing is only

covered if performed in conjunction with pre-authorized Advanced Reproductive Technology

Preimplantation genetic testing is not considered medically necessary for any of the following: • The selection of embryos with specific HLA typing to provide a match for a member in

need of an allogenic transplant • The selection of embryos with the sole purpose of determining the gender of the

resultant offspring.

I. Cryopreservation of Embryos For women in active (authorized) infertility treatment cryopreservation for any embryos

remaining after an authorized IVF cycle (Note: storage is covered only if in active cycle)

Cryopreserved embryos must be used before additional (fresh) IVF cycles using the member's or a donor’s eggs are authorized

If member meets criteria for 2 embryo transfers and only one embryo is available, then a fresh IVF cycle may be authorized if benefit is available

Requests for authorization of a Frozen Embryo Transfer (FET) cycle must meet Infertility criteria (above) at the time of the request for the FET

Limitations — EmblemHealth will not cover the following: • Long-term sperm, oocyte or embryo storage (Note: Storage is only covered for

ova/sperm for iatrogenic infertility) • Sperm cryopreservation as a routine procedure for sperm backup in the absence of a

confirmed physical or psychological diagnosis requiring cryopreservation • An ART cycle when it is known at the initiation of a cycle that none of the resulting

embryos will be transferred during the same cycle, and/or the intent is to cryopreserve all of the embryos for future use, except as outlined above (see Freeze-All Cycles Section E above)

Section 4: IVF for Women without Male Partners or Exposure to Sperm Documentation confirms a female without a male partner or exposure to sperm has failed 6

consecutive AI/IUI cycles using normal donor sperm (Note: Costs of donor sperm are not covered)

The female must also meet Service-Specific Criteria for IVF including documentation of a history of failed medicated IUI cycles. (Note: Age-related embryo transfer requirements outlined in the Service specific criteria for IVF also apply)

Section 5: Donor Services A. Donor Egg (Donor Oocyte)

Non-medical services related to donor egg/embryo or sperm procurement (e.g., finder fees, broker fees, legal fees, medications, donor screening, donor testing, and oocyte retrievals) are not covered

Use of Donor egg during infertility procedures is a covered benefit when infertility criteria are met and there is documentation of any of the following:

Congenital or surgical absence of ovaries

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Premature ovarian failure or premature menopause in women under age 40 years

Premature diminished ovarian reserve (i.e., FSH ≥15 in women under age 40 years)

Inadequate ovarian response (i.e., fewer than 3 follicles >12 mm diameter), or inadequate embryo numbers and quality, during authorized IVF cycles within the prior 6 months (Note: When donor egg criteria are met, a donor egg cycle is authorized for up to 6 months)

A SET is required for members < 35 years of age for the first approved donor egg IVF treatment cycles with more than one top-quality embryo available for transfer

If the donor egg procedure is not performed within 6 months, the member must be reevaluated and continue to meet EmblemHealth criteria for infertility services and donor egg procedures before additional services are authorized For female members (embryo recipients) without EmblemHealth prescription drug coverage, coverage for the egg donor is limited to monitoring (up to egg retrieval), and the egg retrieval procedure

Genetic abnormality (case-by-case review)

Services after oocyte retrieval from donor such as fertilization and transfer are covered when authorized

Limitations: • Infertility treatment when the infertile member is not the recipient of said services (e.g.,

donor egg in conjunction with gestational carrier) • Medications that are directly related to a stimulated ART cycle for anonymous or

designated donors unless medication is for the member • After proceeding to a donor egg cycle, further IVF cycles using the member’s eggs are

not covered

B. Donor Sperm Use of donor sperm of normal quality is authorized when documentation (by any of the following) confirms male factor infertility: Bilateral congenital absence of vas deferens (BCAVD) Non-obstructive Azoospermia confirmed through MESA/TESE results Previous radiation or chemotherapy treatment resulting in abnormal semen analyses Two or more abnormal semen analyses at least 30 days apart A high risk of transmitting the male partner’s genetic disorder to the offspring HIV+ male partner

In order to receive coverage for infertility services, male members must meet either of the following criteria based on semen analysis reports performed within the last 3 months: At least 2 unprocessed/processed semen analyses show <10 million total motile sperm At least 2 unprocessed semen analyses show ≤ 2% strict Kruger normal forms

Non-covered services include but are not limited to the following: Donor sperm without documented biological male factor infertility proven with 2 abnormal

semen analyses with the same defect Donor sperm for biological males with genetic sperm defects For biological females without a biological male partner The cost of donor sperm, IUI, ART, and related services, if the male partner has a history of prior

vasectomy with no subsequent successful vasectomy reversal procedure Cost of procurement of Donor Sperm

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Section 6: Fertility Preservation No infertility workup is required for coverage Covered services for members undergoing chemotherapy that is expected to render them permanently infertile (excluding voluntary sterilization) are as follows: Medically necessary egg retrievals are covered for fertility preservation Sperm collection

Non-covered services include but are not limited to the following: Cryopreservation of embryos or eggs for fertility preservation purposes other than

chemotherapy or other treatments that may render an individual infertile Cryopreservation of embryos or eggs for reciprocal IVF Sperm storage/banking for males requesting this service for convenience or “back-up” for a

fresh specimen Storage of cryopreserved sperm, eggs or embryos (Note: Storage is only covered for ova/sperm

for iatrogenic infertility)

Section 7: Male Infertility Services A. Microepididymal Sperm Aspiration (MESA) Covered only for congenital absence or congenital obstruction of the vas deferens (typically

diagnosed by the absence of fructose in semen) and confirmed by exam

B. Microdissection — Testicular Excisional Sperm Extraction (TESE) Covered for non-obstructive azoospermia and spinal cord injury resulting in inability to ejaculate

Section 8: Limitations/Exclusions

Non-covered tests/procedures include but are not limited to the following: Infertility treatment if, based on the member’s individual medical history, they have < 5%

chance of a birth outcome ART/Infertility services for members when clinical documentation confirms an individual or

couple are using illicit substances or abusing substances known to negatively interfere with fertility or fetal development (e.g. marijuana, opiates, cocaine, tobacco or alcohol)

Infertility treatment when infertility is the result of a non-reversed or unsuccessful reversal of a voluntary sterilization

Ovarian Reserve Assessment results (Clomiphene Citrate Challenge Test [CCCT]) Selective fetal reduction without known disorders that are non-compatible with life Gender selection Human zona binding assay (hemizona test) Serum anti-sperm antibody testing Sperm acrosome reaction test Co-culture of embryos Embryo toxic factor test (ETFL) Ovulation kits In vitro maturation of eggs Direct intraperitoneal insemination (DIPI) Peritoneal ovum and sperm transfer (POST) Genetic engineering

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Egg harvesting, or other infertility treatment performed during an operation not related to an infertility diagnosis

Chromosome studies of a donor (sperm or egg) Infertility services in cases in which normal embryos have been or will be discarded because of

gender selection ICSI for any IVF cycle involving use of donor sperm Treatments requested solely for the convenience, lifestyle, personal or religious preference of

the member in the absence of medical necessity Treatment to reverse voluntary sterilization, i.e. MESA/TESE, for a member who has undergone

prior sterilization Monitoring of non-authorized IUI cycles Reciprocal IVF Oocyte, ovarian or testicular tissue cryopreservation Storage of cryopreserved reproductive materials (i.e., embryos, oocytes, or sperm) (Note:

Storage is only covered for ova/sperm for iatrogenic infertility) Gamete intrafallopian tube transfers (GIFT) or zygote intrafallopian tube transfers (ZIFT) (May be

covered for some plans) Surrogacy (Note: Maternity service benefits may be available for members acting as surrogate

mothers) All experimental/investigational procedures and treatments are not covered for the diagnosis

and treatment of infertility as determined in accordance with the standards and guidelines established and adopted by the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine

Revision History

Feb. 14, 2020 Added pre-implantation genetic testing criteria to ART section

Jan. 17, 2019 Clarified IVF protocol for members between 35–38 years of age Added that SET/STEET is not necessary for members > 38 undergoing IVF

Nov. 25, 2019 Updated commensurate with New York State Mandate eff. Jan. 1, 2020

Applicable Procedure Codes

58321 Artificial insemination; intra-cervical

58322 Artificial insemination; intra-uterine

58323 Sperm washing for artificial insemination

58345 Transcervical introduction of fallopian tube catheter for diagnosis and/or re-establishing patency (any method), with or without hysterosalpingography

58752 Tubouterine implantation

58760 Fimbrioplasty

58970 Follicle puncture for oocyte retrieval, any method

58974 Embryo transfer, intrauterine

76948 Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation

89250 Culture of oocyte(s)/embryo(s), less than 4 days;

89251 Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture of oocyte(s)/embryos

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89253 Assisted embryo hatching, microtechniques (any method)

89254 Oocyte identification from follicular fluid

89255 Preparation of embryo for transfer (any method)

89257 Sperm identification from aspiration (other than seminal fluid)

89258 Cryopreservation; embryo(s)

89259 Cryopreservation; sperm

89260 Sperm isolation; simple prep (e.g., sperm wash and swim-up) for insemination or diagnosis with semen analysis

89261 Sperm isolation; complex prep (e.g., Percoll gradient, albumin gradient) for insemination or diagnosis with semen analysis

89264 Sperm identification from testis tissue, fresh or cryopreserved

89268 Insemination of oocytes

89272 Extended culture of oocyte(s)/embryo(s), 4-7 days

89280 Assisted oocyte fertilization, microtechnique; less than or equal to 10 oocytes

89281 Assisted oocyte fertilization, microtechnique; greater than 10 oocytes

89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos

89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos

89300 Semen analysis; presence and/or motility of sperm including Huhner test (post coital)

89310 Semen analysis; motility and count (not including Huhner test)

89320 Semen analysis; volume, count, motility, and differential

89321 Semen analysis; sperm presence and motility of sperm, if performed

89322 Semen analysis; volume, count, motility, and differential using strict morphologic criteria (e.g., Kruger)

89331 Sperm evaluation, for retrograde ejaculation, urine (sperm concentration, motility, and morphology, as indicated)

89337 Cryopreservation, mature oocyte(s)

89343 Storage (per year); sperm/semen

89346 Storage (per year); oocyte(s)

89352 Thawing of cryopreserved; embryo(s)

89353 Thawing of cryopreserved; sperm/semen, each aliquot

89356 Thawing of cryopreserved; oocytes, each aliquot

Q0115 Postcoital direct, qualitative examinations of vaginal or cervical mucous

S4011 In vitro fertilization; including but not limited to identification and incubation of mature oocytes, fertilization with sperm, incubation of embryo(s), and subsequent visualization for determination of development

S4015 Complete in vitro fertilization cycle, not otherwise specified, case rate

S4016 Frozen in vitro fertilization cycle, case rate

S4017 Incomplete cycle, treatment cancelled prior to stimulation, case rate

S4018 Frozen embryo transfer procedure cancelled before transfer, case rate

S4020 In vitro fertilization procedure cancelled before aspiration, case rate

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S4021 In vitro fertilization procedure cancelled after aspiration, case rate

S4022 Assisted oocyte fertilization, case rate

S4023 Donor egg cycle, incomplete, case rate

S4025 Donor services for in vitro fertilization (sperm or embryo), case rate

S4027 Storage of previously frozen embryos

S4035 Stimulated intrauterine insemination (IUI), case rate

S4037 Cryopreserved embryo transfer, case rate

References New York State Department of Financial Services. IVF and Fertility Preservation Law Q&A Guidance. https://www.dfs.ny.gov/apps_and_licensing/health_insurers/ivf_fertility_preservation_law_qa_guidance. Accessed December 13, 2019.

Agency for healthcare research and quality (AHRQ), U.S. Department of Health and Human Services, National Guideline Clearinghouse | Fertility: assessment and treatment for people with fertility problems. http://guideline.gov/content.aspx

Wang, Ange, M.D., et al. Freeze-Only Versus Fresh Embryo Transfer in a Multicenter Matched Cohort Study: Contribution of Progesterone and Maternal Age to Success Rates. Fertility and Sterility. August 2017; 108 (2): 254-261.

American Society of Reproductive Medicine. A practice committee report: definition of infertility. July 1993. Available online: asrm.org.

Smith, Andrew D., et al. Live-Birth Rate Associated With Repeat In Vitro Fertilization Treatment Cycles. Journal of the American Medical Association. December 2015; 314 (24):2654-2662

Published jointly by the Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, ‘Criteria for number of embryos to transfer: a committee opinion’, Fertility and Sterility. 2013 Jan;99(1):pp. 44-46

ASRM (a). The Practice Committee of the American Society for Reproductive Medicine: Testing and interpreting measures of ovarian reserve. Fertil Steril 2015;103(3):e9-e17.

ASRM: The Ethics Committee of the American Society for Reproductive Medicine. Fertility Treatment When the Prognosis is Very Poor or Futile: a Committee Opinion. Fertil Steril 2012;98:e6–e9.

ASRM: The Practice Committee of the American Society for Reproductive Medicine: Use of Clomiphene Citrate in Infertile Females: a Committee Opinion. Fertil Steril 2013; 100: 341-8.

ASRM: The Ethics Committee of the American Society for Reproductive Medicine. Oocyte or embryo donation to women of advanced reproductive age: an ethics committee opinion. Fertil Steril 2016;106:e3-e7.

ASRM: Mature oocyte cryopreservation: a guideline. Practice Committees of American Society for Reproductive Medicine, Society for Assisted Reproductive Technology. Fertil Steril 2013;99:37–43

Crawford S, Boulet SL, Mneimneh AS, et al. Costs of achieving live birth from assisted reproductive technology: a comparison of sequential single and double embryo transfer approaches. Fertil Steril 2016 Feb;105(2):444–50.

Devine S, Connell MT, Richter KS, et al. Single vitrified blastocyst transfer maximizes liveborn children per embryo while minimizing preterm birth. Fertil Steril. 2015 Jun;103(6):1454–60.

Diamond MP, Legro RS, Coutifaris C, et al. Letrozole, clomiphene or gonadotropin for unexplained infertility. N Engl J Med 2015;373:1230-40

Fauque P, Jouannet P, Davy C, Guibert J, et al. Cumulative results including obstetrical and neonatal outcome of fresh and frozen-thawed cycles in elective single versus double fresh embryo transfers. Fertil Steril 2010;94:927-935.

Fujimoto A, Morishima K, Harada M, et al. Elective single-embryo transfer improves cumulative pregnancy outcome in young patients but not in women of advanced reproductive age. J Assist Reprod Genet. 2015 Dec;32(12):1773–1779.

Griffo J, Hodes-Wertz B, Lee H-L. Single thawed euploid embryo transfer improves IVF pregnancy, miscarriage, and multiple gestation outcomes and has similar implantation rates as egg donation. J Assist Reprod Genet. 2013 Feb;30(2):259-64.

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Milliman Care Guideline: Assisted Reproductive Technology. MCG Ambulatory Care 2013: 17th edition; ACG: A0504 (AC).

Scott, RT. Diminished ovarian reserve and access to care. Fertil Steril 2004; 81:1489-1492.

Shapiro BS, Daneshmand ST, Garner FC, et al. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril 2011;96:344–348.

Shapiro BS, Daneshmand ST, Restrepo H, et al. Matched-cohort comparison of single-embryo transfers in fresh and frozen-thawed embryo transfer cycles Fertil Steril 2013;99:389–92.

Shapiro BS, Harris DC, Richter KS. Predictive value of 72-hour blastomere cell number on blastocyst development and success of subsequent transfer based on the degree of blastocyst development. Fertil Steril 2000;73:582–6.

Mastenbroek S, Twisk M, van Echten-Arends J, et al. In vitro fertilization with preimplantation genetic screening. New Eng J Med. 2007 July;357(1):9-17.

Staessen C, Platteau P, Van Assche E, et al. Comparison of blastocyst transfer with or without pre-implantation genetic diagnosis for aneuploidy screening in couples with advanced maternal age: A prospective randomized controlled trial. Hum Reprod. 2004 Dec;19(12):2849-2858.

Sermon KD, Michiels A, Harton G, et al. ESHRE PGD consortium data collection VI: Cycles from January to December 2003 with pregnancy follow-up to October 2004. Hum Reprod. 2007 Feb;22(2):323-336.

Twisk M, Mastenbroek S, van Wely M, et al. Pre-implantation genetic screening for abnormal number of chromosomes (aneuploidies) in in vitro fertilization or intracytoplasmic sperm injection.

Cochrane Database Syst Rev. 2006 Jan;25(1):CD005291. Verlinsky Y, Cohen J, Munne S, et al. Over a decade of experience with pre-implantation genetic diagnosis. Fertil Steril. 2004 Aug;82(2):302-303.

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Appendix EmblemHealth Pre-Authorization Request Form

Date: Requesting Provider:

Member Name: Requesting Provider ID #:

Member ID #: Tax ID #:

Member DOB and age: Office Contact Name:

Partner/Spouse DOB: Office Contact Phone # and Ext:

Office Contact Fax #:

Treatment date change only? □ Yes □ No If yes, From ____________to

Patient Infertility History

How long has member been trying to conceive? _________ Male, hormonal, or anatomical infertility? __________

History of sterilization? ___________________________________________

How many intrauterine insemination cycles (medicated/non-medicated) has this member received? ____________

Dates ___________________ How many IVF cycles has member had? ________ Dates______________________

Procedure(s) Requested ICD-10/CPT Code(s):

Please check the procedure(s) for which you are requesting coverage:

□ Intrauterine insemination

□ In Vitro fertilization: Fresh _____, Freeze all ______, FET _____ (How many embryos are planned to transfer? ___)

□ AH □ ICSI □ PGT □ Use of donor egg/sperm □ Other _______________

Number of cycles requested

Anticipated length of therapy: From to

Clinical information necessary for pre-authorization request

□ H & P

□ HSG, or related uterine cavity and fallopian tube study (Dated within two years)

□ LMP, Day 3 Labs (E2, FSH), and AMH, dated within 1 year

□ Semen Analysis dated within 1 year (Two dated within last 3 months for severe male factor infertility)

□ Carrier Screening Report for PGT requests

□ Previous infertility treatment records

□ Other clinical information:

Fax form and medical documentation to EmblemHealth IVF at 1-212-946-7516 or email [email protected]. Please Note:

• Services are not considered authorized until EmblemHealth issues an authorization. Lack of information will delay processing of request.

• Additional requests must also include both a completed form and supporting medical documentation.

Contact 1-800-447-8255 with any questions about pre-authorization. This is confidential information

Last reviewed 2/2020